A 2-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Subjects

Completed

Conditions: Mood disorders
10027946

Registration Number: NL-OMON46723

Lead Sponsor: Janssen-Cilag International NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

Healthy male subject between 18 and 54 years of age, inclusive.
Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive
Non-smoker (not smoked for 3 months prior to screening)

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to assess safety and tolerability of day-time and<br /><br>night-time dosing of JNJ-55375515 in healthy male subjects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are to assess:<br /><br>- the influence of daytime dosing of JNJ-55375515 on pharmacodynamic markers<br /><br>including electroencephalography (EEG), heart rate variability (HRV), saccadic<br /><br>eye movement, body sway, sleepiness, mood, neuroendocrinology,<br /><br>emotional/motivational processing and simple- and complex cognition<br /><br>- the effect of JNJ-55375515 administered at day-time on an evoked stress<br /><br>response<br /><br>- the influence of night-time dosing of JNJ-55375515 on sleep architecture<br /><br>using polysomnography;<br /><br>- the influence of night-time dosing of JNJ-55375515 on sleepiness and<br /><br>performance of complex cognitive tasks;<br /><br>- the pharmacokinetics of single-dose morning and evening administration of<br /><br>JNJ-55375515 in healthy male subjects</p><br>